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Ear Washer Bottle

EUDAMED

Class I (EU MDR)

Ref B07G4GYM5KModel Ear Washer

by Fbgc Limited

Identity

Trade Name
Ear Washer Bottle EUDAMED
Device Name
Ear Washer EUDAMED
Model / Reference
Ear Washer EUDAMED
B07G4GYM5K EUDAMED

Identifiers

Primary DI / UDI-DI
05060551221397 EUDAMED
Basic UDI-DI
050605512EarWasherJW EUDAMED
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Device sterilization/disinfection container, reusable

Ear Washer Bottle by Fbgc Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Fbgc Limited
EUDAMED SRN
UK-MF-000046785
Authorised Representative
AF Pharma Service Europe SL ES-AR-000018076

Sources (1)

  • EUDAMED 68ca190d-5477-4ed7-9323-24b1e751d540 61 fields · synced Jun 19, 2026